The Clinical Coordinating Center (CCC) for Pediatric Multicenter Studies provides principal investigators (PIs) at Johns Hopkins All Children’s Hospital with the infrastructure and supportive expertise to successfully lead and conduct multicenter pediatric studies. This is accomplished by leveraging the existing resources within the Johns Hopkins All Children’s Institute for Clinical and Translational Research (ICTR) and All Children’s Research Institute (ACRI) and applying them to the overall management and organization of a multicenter study. 
 
Led by a team of experienced multicenter study project managers (PMs), the CCC manages the project through each phase of the study lifecycle from start-up through close out and manuscript publication. 

• In collaboration with the PI, PMs develop and revise all multicenter study essential documents and related materials, including the protocol, investigator's brochure (IB), consent, eligibility checklist, visit window tracking tools and operations manuals.

• PMs assist the PI in selecting highly reliable sites with a proven track-record of accrual and compliance. 

• PMs maintain CCC IRB approvals (local, single or central) as well as on an ongoing basis the study’s overall Trial Master File (TMF) of regulatory documents. 

• PMs partner with the PI to provide training to site staff at initiation as well as on an ongoing basis through monthly conference calls and webinars as well as annual investigator meetings.

• In collaboration with the PI and study biostatistician, the PMs develop and test Case Report Forms (CRFs).

• In collaboration with the Johns Hopkins All Children's ICTR Regulatory Affairs/Quality Assurance Unit, PMs perform remote monitoring of a participating site’s regulatory documentation and study data to ensure data accuracy, completeness and integrity. 

For those multicenter clinical trials using an investigational drug/device biologic, the CCC interfaces and coordinates with:

• The Johns Hopkins All Children’s ICTR Investigational New Drug/Investigational Device Exemption (IND/IDE) Support Unit, to prepare and submit the initial application for IND/IDE to the Food and Drug Administration as well as all amendments and annual reports. 

• The Johns Hopkins All Children's ICTR Investigational Drug Services (IDS) Unit, to provide centralized IDS, shipping Investigational Product (IP) to participating sites and maintaining overall IP accountability.

For those studies collecting biological samples, the CCC interfaces and coordinates with the Johns Hopkins All Children’s Pediatric Biorepository to design, prepare and ship kits for sample collection, receipt, and to coordinate return shipment, receipt and storage of biological samples, with accompanying sample tracking information. 
 
The CCC interfaces and coordinates with the Johns Hopkins All Children’s Department of Research & Grants Administration to facilitate all contracting with participating sites and site reimbursement for study activities and milestones.
 
The CCC provides Independent Committee (e.g., Steering, Clinical Endpoint Adjudication, and Data and Safety Monitoring) set-up and management services, depending upon scope and Sponsor mechanism.

Current Studies Supported:

Kids-DOTT

Johns Hopkins All Children’s is the Clinical Coordinating Center for the Kids-DOTT trial, an NIH-Sponsored multinational randomized clinical trial (RCT) to establish the duration of anticoagulation for venous thromboembolism in children whose primary findings were published in 2022 in JAMA.

This final included Central Investigational Pharmacy and Central Biorepository roles.

CoVAC-TP 

Johns Hopkins All Children's was the Clinical Coordinating Center for the CoVAC-TP trial, a national Phase 2 clinical trial to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin for in-hospital venous thromboembolism prophylaxis in children hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19) including multisystem inflammatory syndrome in children (MIS-C).

Vorinostat Dose-Escalation Post-Transplant Study

To evaluate the maximum tolerated (MTD) of vorinostat used in combination with low-dose azacitidine after allogeneic hematopoietic cell transplantation (alloHCT) for childhood myeloid malignancies.